VABOMERE

批准信原文要点

This Prior Approval sNDA provides for the addition of “Hepatobiliary Disorders: drug- induced liver injury (DILI), including hepatitis and liver failure” to the ADVERSE REACTIONS (6) section, Postmarketing Experience (6.2) subsection of the Prescribing Information (PI). Minor editorial revisions were also made throughout the Prescribing Information.

批准信原文要点

This supplemental new drug application provides for revisions to the labeling for Vabomere for injection, consistent with our August 20, 2024 letter.

批准信原文要点

This Prior Approval sNDA provides for: • Revisions to the HIGHLIGHTS OF PRESCRIBING INFORMATION, TABLE OF CONTENTS, and FULL PRESCRIBING INFORMATION. Specifically, o Under the HIGHLIGHTS OF PRESCRIBING INFORMATION, the DRUG INTERACTIONS section was inserted to add clinically significant drug interaction information with hormonal contraceptives. o Under the TABLE OF CONTENTS, Section 7 DRUG INTERACTIONS was revised to add subsections 7.3 Potential for Vabomere to Affect Other Drugs, 7.4 Hormonal Contraceptives, and Section 8, USE IN SPECIFIC POPULATIONS was revised to add subsection 8.3 Females and Males of Reproductive Potential.

批准信原文要点

This Prior Approval supplemental new drug application provides for the inclusion of the following statement in subsection 12.2 Pharmacodynamics: “Cardiac Electrophysiology At a dose of 1 and 3 times the maximum approved recommended dose, Vabomere (meropenem and vaborbactam) does not prolong the QT interval to any clinically relevant extent.”

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for changes to the DOSAGE AND ADMINISTRATION, Preparation and Administration of VABOMERE for Intravenous Infusion (2.3) section of the label as specified in the CBE Supplement Request letter dated March 20, 2018.